Phase 3 Clinical Study IND Accepted in China for Alimera’s Fluocinolone Acetonide Intravitreal Implant

Alimera Sciences announced that its partner, Ocumension Therapeutics, received approval from the National Medical Products Administration for its IND application to begin the phase 3 clinical study for fluocinolone acetonide intravitreal implant in support of a filing for marketing approval to treat diabetic macular edema in mainland China.

“We are very excited by the progress that Ocumension is making toward generating the data needed to seek approval in China for our intravitreal implant,” Rick Eiswirth, President and CEO of Alimera, said in a company news release. “We look forward to the start of the trial and to the subsequent data.”

The IND application was for a randomized, multicenter phase 3 clinical study of 0.19 mg Fluocinolone Acetonide Intravitreal Implant in the treatment of diabetic macular edema. The intent of the trial is to support a future NDA filing to gain marketing approval in the country with an equivalent indication to Alimera’s U.S. indication (for the treatment of diabetic macular edema previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure).